What is the mechanism of action of this treatment?

The most common treatments for solid tumors often involve immune-based therapies that enhance the body's natural ability to fight cancer. Tislelizumab, an anti-PD-1 antibody, blocks the PD-1/PD-L1 pathway, preventing cancer cells from evading immune detection. Agents like BGB-A425 and LBL-007 likely work synergistically to further stimulate the immune response. These mechanisms are significant for solid tumor patients as they offer a more targeted approach, potentially leading to better outcomes and reduced toxicity compared to conventional treatments.

What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those involving immune checkpoint inhibitors like Tislelizumab, include fatigue, rash, diarrhea, and endocrine disorders such as hypothyroidism. More severe immune-related adverse events can involve pneumonitis, hepatitis, colitis, and nephritis. Infusion-related reactions, including fever, chills, and nausea, are also frequently observed.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of solid tumors, focusing on enhancing the immune response against cancer cells. Notable approvals include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which are PD-1 inhibitors, and atezolizumab (Tecentriq), a PD-L1 inhibitor. These drugs have shown efficacy in various cancers, including non-small cell lung cancer, melanoma, and urothelial carcinoma, by blocking the PD-1/PD-L1 pathway and allowing T-cells to attack cancer cells more effectively.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) Atezolizumab in combination with carboplatin and etoposide, which has shown improved overall survival and progression-free survival in extensive-stage small cell lung cancer. 2) Durvalumab plus platinum-etoposide, which has demonstrated improved survival outcomes in the CASPIAN trial for extensive-stage small cell lung cancer. 3) Talimogene laherparepvec (T-VEC) combined with pembrolizumab, which has shown promise in advanced melanoma. These therapies enhance the immune response against cancer cells and have demonstrated efficacy in clinical trials.

Monoclonal Antibodies

BGB-A425 + LBL-007 + Tislelizumab for Solid Cancers

Suwon, Korea, Republic of

Phase 1 & 2

Waitlist Available

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.

Adequate organ function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase 1 or 2 expansion - approximately 2-3 years each

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new drug combinations to help the immune system fight advanced solid tumors better. It targets patients who do not respond well to existing treatments by blocking proteins that cancer cells use to hide from the immune system.

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Who is the study for?

This trial is for adults with certain advanced solid tumors, including specific types of head and neck, lung, or renal cancers. Participants must have a good performance status (able to carry out daily activities), proper organ function, and no major health issues like severe allergies to monoclonal antibodies or uncontrolled diabetes. They should not have received other recent cancer treatments or be part of another clinical study.Check my eligibility

What is being tested?

The study is testing the combination of three drugs: BGB-A425, LBL-007, and Tislelizumab in patients with advanced solid tumors. It's an early-phase trial that includes both initial dose-finding (Phase 1) and later-stage evaluation (Phase 2) to assess safety and effectiveness.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the drugs used, immune-related issues affecting organs due to Tislelizumab which is an immunotherapy drug; as well as general side effects such as fatigue, nausea, skin reactions from BGB-A425 and LBL-007.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all my pre-disease activities without restriction.

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My organs are working well.

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I have an advanced cancer that cannot be removed by surgery and have tried or cannot undergo standard treatment.

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Phase 2 Dose-Expansion: Participants with one of the following histologically or cytologically confirmed solid tumors: For HNSCC participants in cohort 1,4 and 6 (PD-L1 positive): Recurrent/metastatic head and neck squamous cell cancer of the oral cavity, oropharynx, hypopharynx, and/or larynx whose tumor is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy • For NSCLC participants in Cohort 2, 5 and 7 (PD-L1 positive): Locally recurrent Stage IIIB, stage IIIC or Stage IV squamous or non-squamous non-small cell lung cancer • For RCC participants in Cohort 3: Locally advanced unresectable or metastatic and histologically confirmed renal cell carcinoma with a clear cell histology

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase 1 or 2 expansion - approximately 2-3 years each

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase 1 or 2 expansion - approximately 2-3 years each

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 1 or 2 expansion - approximately 2-3 years each for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1 Dose Escalation and Phase 2 Safety lead-in: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Phase 1 Dose Escalation: Maximum Tolerated Dose (MTD)

Phase 2 Dose Expansion: Objective Response Rate (ORR)

Secondary study objectives

Phase 1 and Phase 2 : Disease control rate (DCR)

Phase 1 and Phase 2 : Duration of Response (DOR)

Phase 1 and Phase 2 : Progression free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2 Safety Lead-inExperimental Treatment3 Interventions

Dose escalation for Cohort A (LBL-007 + Tislelizumab) and Cohort B (BGB-A425 + LBL-007 + Tislelizumab) in participants with advanced solid tumors

Group II: Phase 2 Dose ExpansionExperimental Treatment3 Interventions

Further explore the safety and clinical activity of BGB-A425 and LBL-007 in combination with Tislelizumab in participants with NSCLC, HNSCC and RCC

Group III: Phase 1 Dose EscalationExperimental Treatment2 Interventions

Dose escalation of BGB-A425 in combination with Tislelizumab in participants with advanced solid tumors

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LBL-007

2018

Completed Phase 2

~240

Tislelizumab

2018

Completed Phase 3

~4790

BGB-A425

2018

Completed Phase 2

~120

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors often involve immune-based therapies that enhance the body's natural ability to fight cancer. Tislelizumab, an anti-PD-1 antibody, blocks the PD-1/PD-L1 pathway, preventing cancer cells from evading immune detection. Agents like BGB-A425 and LBL-007 likely work synergistically to further stimulate the immune response. These mechanisms are significant for solid tumor patients as they offer a more targeted approach, potentially leading to better outcomes and reduced toxicity compared to conventional treatments.